Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Enrofloxacin
Elanco GmbH
QJ01MA90
Enrofloxacin
150 mg/tablet
Tablet
POM: Prescription Only Medicine as defined in relevant national legislation
enrofloxacin
Authorised
1988-10-01
Health Products Regulatory Authority SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Baytril Flavour Tablets 150 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Constituents mg/tablet Enrofloxacin 150.0 Relevant constituents of the Excipient Artificial beef flavour Irradiated 42.0 For full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Tablet. Light brown to brown, slightly marbled, round, curved, scored tablets for oral administration to dogs 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES The product is for use in dogs in the treatment of bacterial infections of the alimentary, respiratory and urogenital tracts, skin, secondary wound infections and otitis externa where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of the choice. 4.3 CONTRAINDICATIONS Not for use in dogs less than 1 year of age or in exceptionally large breeds of dog with a longer growth period under 18 months of age, as articular cartilage may be affected during the period of rapid growth. Baytril Flavour Tablets 150 mg should not be used for prophylaxis. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Please see point 4.3. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR US IN ANIMALS Do not exceed the recommended dose. Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials. Whenever possible, fluoroquinolones should only be used based on susceptibility testing. Use of the product deviating from instructions given in the SPC may increase the prevalence of bacteria resistant to fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance. Official and local antimicrobial policies should be taken into account when the product is used. In cases of pyoderma, possible underlying p Aqra d-dokument sħiħ